Clinical Research Associate
- Jobs Wind
- 0 Years - 6 Months
- Banglore,India
- 4 years ago
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- Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice (GCP) guidelines, and other applicable regulatory requirements.
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP guidelines.
- Review informed consent document / procedures.
- Negotiate study budgets with potential investigators and assists with the execution of site contracts Provide monitoring visits and site management for a variety of protocols, sites
- Administer protocol and other study-related training to assigned site personnel and establish regular lines of communication with the sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of the practices of the study site related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalate quality issues to the CPM / line manager, as deemed necessary.
- Ensure accurate data reporting via review of site source documents and medical records.
- Interpret data to identify protocol deviations and risks to subject safety/data integrity.
- Perform investigational product accountability as per the protocol and Study Monitoring Plan.
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